奥美拉唑碳酸氢钠干混悬剂溶出度方法学研究

Study on the Dissolution Method of Omeprazole Sodium Bicarbonate Dry Suspension

目的:考察奥美拉唑碳酸氢钠干混悬剂溶出度方法学,对比自研样品与参比制剂在溶出介质中的溶出行为。方法:桨法,HPLC法,溶出介质是pH=7.4的磷酸盐缓冲液。结果:在0.759 6~18.230 0μg/mL范围内线性良好,精密度6次进样的RSD<2.0%,平均回收率为99.31%,RSD为0.71%。结论:该溶出度方法系统适用性良好,准确度高,适合奥美拉唑碳酸氢钠干混悬剂溶出度的测定。

Objective:To investigate the dissolution methodology of omeprazole sodium bicarbonate dry suspension and compare the dissolution behavior of self-developed samples and reference formulations in the dissolution medium.Method:Paddle method,HPLC method,dissolution medium is phosphate buffer solution with pH 7.4.Result:The linearity was good within the range of 0.7596~18.2300μg/mL,with a precision of less than 2.0%for 6 injections,an average recovery rate of 99.31%,and an RSD of 0.71%.Conclusion:This dissolution method has good applicability and high accuracy,and is suitable for determining the dissolution of omeprazole sodium bicarbonate dry suspension.